The culture of an organization is key to its success. That culture is directly linked to the organization’s mission and how it operates on a day-to-day basis. We are very fortunate that our mission is centered around helping patients with novel therapies, which is exciting and fulfilling for our whole team. Also, keeping things as simple as possible is the key to success. The more complicated a process or model becomes, the more unlikely it will provide a long-term solution to the problem.
As a part of our series about “Big Ideas That Might Change The World In The Next Few Years” we had the pleasure of interviewing Boro Dropulić.
Boro Dropulić, Executive Director and Co-Founder of Caring Cross, received his PhD from the University of Western Australia and his MBA from the Johns Hopkins University (JHU) has worked in the gene therapy field since the late 1980s.
After a Fogarty Fellowship at the NIH, he joined the faculty at JHU where he worked on developing Lentiviral vectors as delivery systems for gene therapy. After 4 years in academia, he founded his first company ViRxSys and led the team that first demonstrated the safety of Lentiviral vectors in humans with his UPenn colleagues. Later he founded Lentigen, which first developed the Lentiviral vector used to produce Kymriah™, the first FDA-approved gene therapy product.
Later, Boro saw an opportunity to integrate Lentiviral vector technology with closed-system automated cell processing devices to enable distributive place-of-care manufacturing at hospitals, potentially improving the affordability and accessibility of gene therapy products like CAR-T cells. He therefore spearheaded the acquisition of Lentigen by Miltenyi Biotec in 2014 and led the development of a global place-of-care network of clinical centers that were able to successfully manufacture CAR-T cell products and demonstrate their therapeutic benefits in clinical trials.
Seeing a need for improved business models to support the affordability and accessibility of gene therapy products, Boro co-founded Caring Cross and serves as the Executive Director.
Thank you so much for doing this with us! Before we dig in, our readers would like to get to know you a bit. Can you please share with us the most interesting story that happened to you since you began your career?
I have been working in the field of gene therapy since the late 1980s. I have spent most of that time developing a gene delivery system that uses a lentiviral vector to efficiently deliver specific genes to patient cells to treat and potentially cure various diseases. My team was the first to establish the safety of lentiviral vectors in humans and later created the vector that became the basis for Kymriah, the first FDA-approved gene therapy product, which is used in the treatment of leukemia patients.
Which principles or philosophies have guided your life? Your career?
My father escaped from communism after World War II and was a refugee before settling in Australia. I grew up appreciating the freedom and opportunities I have been given, that hard work and excellence are important, and that we have a responsibility to help each other, especially if we have been given opportunities that others may not have had due to their life circumstances. This is especially true for people who suffer from disease. Gene therapy is powerful since it is potentially curative for many diseases. I have seen how it can transform people’s lives. When a person with a life-threatening disease is cured and given another chance, it can not only be transformative for that person, but it creates a multiplier effect, because a person cured of a life-threatening disease is almost always grateful for a second chance, and gives back to the community with greater vigor. This is also true for family members. A great example is Emily Whitehead, who was cured by CAR-T cell therapy. Her family established a foundation to help others with leukemia.
Ok thank you for that. Let’s now move to the main focus of our interview. Can you tell us about your “Big Idea That Might Change The World”?
Gene therapies are the future of medicine. They are potentially curative for many diseases, such as HIV, cancer, genetic disorders, and other serious conditions, since genes can be used as molecular tools to improve a patient’s cell’s ability to fight disease long-term in the body. We have already seen gene therapy cure some patients with leukemia, lymphoma and sickle cell disease. These therapies have the potential to transform lives, offering cures where none existed before. There is no reason why gene therapy cannot tackle the majority of diseases that plague mankind.
Actually, I believe that in the future, all diseases will be treated in this way since these therapies are highly targeted, have shown improved efficacy with lower side effects than competing therapies, and they can be curative with one course of therapy.
However, the journey from laboratory to patient is fraught with challenges. The manufacturing and logistics processes are long, slow, and prohibitively expensive. This centralized approach often results in devastating delays, sometimes making it tragically too late for patients in desperate need.
Adding to this heartbreak is the financial barrier. At $370,000 to over $3,000,000 for each dose, many patients who could benefit from gene therapy are priced out. This staggering expense means that life saving therapies remain out of reach for too many. Additionally, many insurance providers, especially government payers, are already beginning to limit access, further exacerbating the crisis of affordability and accessibility.
Currently, no one is tackling the high-cost issue. Rather, the industry is taking the position of justifying the high cost. But these therapies do not need to be so expensive. I know this is the case because I have been in the field for decades and our collaborators at hospitals have shown that these products can be produced at a much lower cost.
We must dismantle these barriers to ensure that everyone, regardless of financial status or location, can access these advanced medicines promptly and affordably. In response to this urgent need, I co-founded Caring Cross, a 501(c)(3) nonprofit organization dedicated to accelerating the development of advanced medicines and guaranteeing access for all patients, everywhere. Our mission targets the three greatest obstacles to patient access to cell and gene therapies (CGT): cost, geography, and time.
Our “big idea” is to reduce the cost of the therapies by at least 10-fold and work towards them being even less costly in parts of the world where skilled labor can significantly reduce the cost further.
One way to do this is to transfer the technology to countries so that they can make these therapies locally for themselves. At Caring Cross, we are working with another nonprofit in Brazil called Fiocruz, and in collaboration with the Brazilian Ministry of Health, transferring the technology to manufacture gene therapies to that country so that they can make them for one-tenth of the price of the commercial products.
We are initiating similar collaborations in other countries around the world. In addition, the products will be made at hospitals that are close to where patients come for care, rather than at centralized manufacturing facilities that lead to higher costs due to transportation and the complex logistics associated with centralized manufacturing.
Through our efforts, we hope to bring these groundbreaking therapies within reach, so that no one is left to suffer needlessly due to economic or logistical constraints. The time to act is now; we must make these future medicines a reality for all.
How do you think this will change the world?
Imagine a world where groundbreaking therapies are not limited by geography or wealth, but are universally accessible to those who need them most; a world that is no longer a distant dream, but a vision we are working tirelessly to make a reality
Currently, only 25% of people eligible for CAR-T cell gene therapies obtain them in the U.S., and that number drops to less than 1% in low- and middle-income countries. But people in desperate need of CAR-T cell therapy will soon be able to gain faster and more affordable access to these lifesaving treatments thanks to our work in partnership with other organizations and companies. Technology transfer coupled with point-of-care (POC) manufacturing will significantly increase access to these therapies and get them to the patients who most need them, especially in marginalized and underserved communities.
For example, to overcome the exorbitant price, complicated logistics and protracted vein-to-vein time of current gene therapies, we partnered with a Florida company called GermFree, a leading innovator in modular cleanroom infrastructure and services, to manufacture cell and gene therapies (CGT) near or at clinical centers where patients come for care. By using this POC manufacturing model, lifesaving CGT therapies can be made widely available in far flung locations that would ordinarily be beyond the reach of current industry capabilities.
With a modest investment, clinical centers and affiliated organizations could leverage their existing capabilities to manufacture CAR-T and other CGT products in an affordable and sustainable manner. Our goal is to empower clinical centers so they have options to access these potentially life-saving therapies for their patients at a cost that is affordable and sustainable.
GermFree is building on its decentralized laboratory experience to drive the facility innovation, including hardware and digital platforms to enable strong quality controls, while Caring Cross will supply the workflows and details on how to make the therapy, which has been designed to leverage and improve on commercial CAR-T therapies, as well as train doctors and health organizations on the manufacture of the therapy.
In collaboration with GermFree and the Brazilian government’s Fundação Oswaldo Cruz (Fiocruz), Caring Cross is demonstrating how local CAR-T manufacturing can be achieved globally. This partnership aims to showcase how gene therapies can be produced locally in any country with the necessary equipment, starting with Brazil.
Keeping “Black Mirror” and the “Law of Unintended Consequences” in mind, can you see any potential drawbacks about this idea that people should think more deeply about?
Point-of-care (POC) manufacturing for gene therapy products at hospitals is more challenging than centralized manufacturing since many sites will be making the product and this strategy is new. However there are many business models that use local manufacturing. For example, bone marrow transplantation has been performed locally in hospitals for decades with great success. There is no technical reason why POC manufacturing of these products is not possible. In fact, I see POC as the only way that these products will be manufactured and distributed in the future due to the need to improve their affordability and distribution to patients in geographically diverse regions. Patients have a difficult time traveling long distances and leaving their families to obtain such therapies, especially those that are not sufficiently wealthy to take extended time off from work to receive the therapy.
Was there a “tipping point” that led you to this idea? Can you tell us that story?
Like many of my colleagues, I have been working in the gene therapy field for over 30 years. I have seen patients cured of their disease by gene therapy. However, I have also seen the pricing effects of applying a drug model to a highly personalized therapy. In gene therapy, you make each product for each patient using their own cells. The traditional drug distribution model does not fit gene therapy. We needed to find an alternative approach. The ideal of POC manufacturing is not new, but my colleagues and I have been incrementally implementing this idea over the last decade. The idea is being further tested at Caring Cross where we bring together a number of solutions to make POC manufacturing of gene therapy products feasible so that they are affordable and can reach patients around the world who need these potentially lifesaving therapies.
What do you need to lead this idea to widespread adoption?
We are developing partnerships with a diverse range of organizations to bring this idea to reality around the world. For example, we have partnered with Fiocruz and Brazil’s ministry of health to transfer CAR-T cell technology to that country for one-tenth of the price. Similarly, we have partnered with an Indian biotech company to bring our CAR-T cell therapy products to India. We are also partnering with a hospital network in the USA to bring these therapies to disadvantaged patients who are solely insured by Medicare or Medicaid. We are looking for like-minded partners to help us enable hospitals, health systems and other organizations to bring these therapies to their local communities using a model that is both affordable and sustainable over the long term.
What are your “5 Things I Wish Someone Told Me Before I Started” and why.
The culture of an organization is key to its success. That culture is directly linked to the organization’s mission and how it operates on a day-to-day basis. We are very fortunate that our mission is centered around helping patients with novel therapies, which is exciting and fulfilling for our whole team. Also, keeping things as simple as possible is the key to success. The more complicated a process or model becomes, the more unlikely it will provide a long-term solution to the problem. For example, many in the industry believe that the solution to the present high cost is creating very complex automated devices. However, complex devices are not necessarily low cost and they may simply substitute one high cost for another. A simple manufacturing process using local skilled labor not only lowers the cost, but empowers local communities to employ and partake in the technology used to provide these therapies for their patients.
Can you share with our readers what you think are the most important “success habits” or “success mindsets”?
I think the most important success habit or mindset is to clearly understand the final goal and work back through all the steps you need to accomplish that goal. Also, I think it is important to maintain flexibility as things invariably change and you need to be able to respond to those changes. I like the concept of the huddle in American football. At each play the team huddles to plan a course of action. The placement of the ball on the field is not predictable, but given the set of parameters, they can plan a play that responds to the situation. The same is true in research and development. You don’t know the result of the experiment, but once you have the data you can then plan the next course of action until the goal is ultimately achieved.
Some very well known VCs read this column. If you had 60 seconds to make a pitch to a VC, what would you say? He or she might just see this if we tag them 🙂
Gene therapy is the future of medicine. To be part of that future, you not only have to create good technologies, but you have to ensure that these products are affordable in a sustainable way so that they can be reimbursed and create value for all stakeholders. Caring Cross is a nonprofit that catalyzes affordable and sustainable gene therapies. Caring Cross has spun-out a for-profit company called Vector BioMed that manufactures lentiviral vectors in a highly affordable manner. A lentiviral vector is the key delivery tool for many gene therapies. Creating technologies and products that are coupled with simple and affordable materials and processes will transform the gene therapy space and fulfill the promise of bringing these lifesaving therapies to all patients that need them.
How can our readers follow you on social media?
To stay up-to-date on Caring Cross and our initiatives, follow us on Facebook, LinkedIn, or X. You can also visit our website to learn more about getting involved.
Thank you so much for joining us. This was very inspirational.